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Expanding Access to Home-Based Palliative Care

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ClinicalTrials.gov Identifier: NCT03128060
Recruitment Status : Not yet recruiting
First Posted : April 25, 2017
Last Update Posted : April 25, 2017
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Susan Enguidanos, University of Southern California

Brief Summary:
This study will test the effectiveness of integrating an evidence-based model of home-based palliative (HBPC) within primary care clinics on patient and caregiver outcomes. The investigators will conduct a randomized controlled trial, randomizing 1,155 seriously ill patients (and approximately 884 family caregivers) who receive primary care from 10 regional accountable care organizations (ACOs) in California to one of two study groups: HBPC or enhanced usual care (EUC). Follow-up data will be collected via telephone surveys with patients at 1- and 2-months and with caregivers at 1- and 2-months, and, as appropriate, following the death of the patient.

Condition or disease Intervention/treatment Phase
Cancer Congestive Heart Failure Chronic Obstructive Pulmonary Disease Other: Home-based palliative care Other: Enhanced usual care Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Expanding Access to Home-Based Palliative Care Through Primary Care Medical Groups
Estimated Study Start Date : July 1, 2017
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
Experimental: Home-based Palliative Care
Home-based palliative care features home visits by an interdisciplinary PC team (physician, nurse, social worker, and chaplain) that provides pain and symptom management, psychosocial support, advance care planning, disease management education, spiritual and grief counseling, and other services as needed.
Other: Home-based palliative care
The HBPC model consists of home visits by an interdisciplinary primary palliative care team (a physician, nurse, social worker, and chaplain). This team provides pain and symptom management, psychosocial support, advance care planning, spiritual counseling, grief counseling, and other services to meet patient and caregiver needs. Within the first week of a patient's enrollment, team members separately visit the patient at home to assess his/her needs as well as the needs of his/her caregiver. Following the patient's initial assessment, subsequent home visits are based on the patient's and caregiver's needs. At a minimum, a core team member visits the patient at home once per week. Additionally, a 24/7 helpline provides access to nurse counseling and after-hours home visits as needed. As a patient's health declines and he/she becomes eligible for hospice care, HBPC clinicians will refer the patient to hospice.
Other Name: Home-based primary palliative care

Active Comparator: Enhanced Usual Care
Enhanced usual care refers to usual primary care provided by a primary care physician who has received special training in the core elements of palliative care.
Other: Enhanced usual care

Usual primary care consists of appointment-based access to primary care providers (PCPs) as requested by the patient. These PCPs provide family/internal medicine services as well as access to specialist care. They also offer disease case management and pain and symptom management.

These usual care services are enhanced through training in palliative care provided to PCPs. The training addresses core elements of palliative care, specifically these 6 topics: a palliative care overview; strategies for improving patient-provider communications; instruction in ACP; instruction in managing patients' pain and symptoms; care coordination; and preventing medical crises.





Primary Outcome Measures :
  1. Change in Score on Condensed Memorial Symptom Assessment [ Time Frame: At baseline and 1- and 2- months following baseline ]
    This is a brief and reliable (Cronbach alpha: 0.85) self-report assessment that measures the frequency and intensity of a variety of physical and psychological symptoms.

  2. Change in Score on Hospital Anxiety and Depression Scale [ Time Frame: At baseline and 1- and 2- months following baseline ]
    The assessment consists of 14 patient-reported items, with seven questions reflecting anxiety (HADS-A) and seven reflecting depression (HADS-D).


Secondary Outcome Measures :
  1. Change in Score on PHQ-9 [ Time Frame: At baseline and 1- and 2- months following baseline ]
    This is a 9-item assessment to diagnose depression. It is based on the nine DSM-IV criteria for depression

  2. Change in Score on Pain Numerical Rating Scale [ Time Frame: At baseline and 1- and 2- months following baseline ]
    This is an 11-point (0 to 10) pain assessment that is valid (α=.83) and reliable (α=.85) in assessing pain change.

  3. Change in Score on Hearth Hope Index [ Time Frame: At baseline and 1- and 2- months following baseline ]
    This 12-item scale is used to assess hope as it relates to a person's ability to cope with medical illness, loss, and related psychosocial stressors.

  4. Change in Consultation Care Measure [ Time Frame: At baseline and 1- and 2- months following baseline ]
    This patient-reported assessment evaluates patient-physician relationships, including communication, approach to the problem, and interest in the patient's life.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age or older;
  2. diagnosis of HF, COPD, or advanced cancer;
  3. one or more hospitalizations or ED visits in the previous year;
  4. a Palliative Performance Scale score of 70% or less;
  5. English- or Spanish-speaking; and
  6. PCP assessment that he/she "would not be surprised" if the patient died within a year.

Exclusion Criteria:

  1. is receiving hospice care;
  2. has end-stage renal disease; and/or
  3. lives in a nursing home.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03128060


Contacts
Contact: Susan Enguidanos, Ph.D. (213) 740-9822 enguidan@usc.edu
Contact: Anna Rahman, Ph.D. 513-258-4421 rahmananna1@gmail.com

Sponsors and Collaborators
University of Southern California
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Susan Enguidanos, Ph.D. USC Davis School of Gerontology

Responsible Party: Susan Enguidanos, Associate Professor of Gerontology, University of Southern California
ClinicalTrials.gov Identifier: NCT03128060     History of Changes
Other Study ID Numbers: PCORI-1234
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Failure
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases